510(k) Report

510(k) · Cleared

Cleared

Cep 8 Spectrumorange Dna Probe Kit

K953591510(k) TraditionalCleared Nov 29, 1996486-day reviewClass II21 CFR 866.4700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vysis · OYU Dna-Probe Kit, Human Chromosome

Cleared on Nov 29, 1996 after a 486-day review. The FDA summary names no predicate by number.

Decided
Nov 29, 1996
Review
486 days
Class
Class II
Product code
OYU
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K953591Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OYU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All OYU devices

OYU Dna-Probe Kit, Human Chromosome: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OYU

FDA has decided no OYU device since 2007.

Median 510(k) review, days · OYU

Too few OYU 510(k)s in any year since 2007 to give a median.

Recalls per year · OYU

No recall names OYU since 2007.

Adverse event reports per year · OYU

1in 2024

2022: 22023: 12024: 1
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code OYU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—02
20230—01
20240—01
20250—00
20260—0—

What is it indicated for?

This assay is designed to provide a method for the detection and quantification of chromosome 8 in both interphase nuclei and metaphase spreads by fluorescence in situ hybridization (FISH).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Vysis

9 FDA decisions under this applicant name. See the company

  • DEN040010Vysis Autovysion SystemVysis · 2004
  • K033982Modification to Vysis Urovysion Bladder Cancer Recurrence TestVysis · 2004
  • K013785Urovysion Bladder Cancer Recurrence KitVysis · 20021 recall
  • K011031Vysis Urovysion Bladder Cancer Recurrence KitVysis · 20011 recall
  • K010288Aneuvysion Muliticolor Dna Probe KitVysis · 2001

Recent decisions in OYU

The OYU category page

  • K010288Aneuvysion Muliticolor Dna Probe KitVysis · 2001
  • K972200AneuvysionVysis · 1997

https://510kreport.com/device/K953591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953591: Cep 8 Spectrumorange Dna Probe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953591

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026